XXXXXXXXX XXXXXXXXXX KOMISE (XX) 2020/528
xx xxx 14. xxxxx 2020,
xxxxxx xx schvalují xxxxxxxxxx x Xxxxxxxx, Xxxx, Xxxxx Xxxxxx, Xxxxxxxxx xxxxxxx a Xxxxxxx xx účelem xxxxxxxxx xxxxxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxxx očkovacích xxxxx xxxxx vzteklině x xxx, xxxxx x xxxxxx
(xxxxxxxx xxx xxxxxx C(2020) 2103)
(Xxxx x xxxxxxxx xxx XXX)
XXXXXXXX XXXXXX,
x xxxxxxx xx Smlouvu x xxxxxxxxx Evropské xxxx,
x ohledem na xxxxxxxxxx Rady 2000/258/XX xx xxx 20. xxxxxx 2000 x xxxxxx xxxxxxxxxx xxxxxxxxx xxxxxxxxxxx za xxxxxxxxx xxxxxxxx nezbytných pro xxxxxxxxxxx xxxxxxxxxxxxx testů xxx xxxxxxxxx xxxxxxxxx xxxxxxxxxx látek xxxxx xxxxxxxxx&xxxx;(1), x xxxxxxx xx čl. 3 xxxx. 2 uvedeného xxxxxxxxxx,
xxxxxxxx x xxxxx xxxxxxx:
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(1) |
Xxxxxxxxxx 2000/258/ES xxxxxx xxxxxxxxx Xxxxxx xxxxçxxxx xx sécurité xxxxxxxxx xxx xxxxxxxx (xxxx xxx „AFSSA“) ve xxxxxxxxxxxx Nancy xxxx xxxxxxxx institut xxxxxxxxx xx xxxxxxxxx kritérií xxxxxxxxxx pro xxxxxxxxxxx xxxxxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxx xxxxx vzteklině. XXXXX xxxx xxxx xxxxxxxxx do Xxxxxx xxxxxxxxx xx sécurité xxxxxxxxx de l’alimentation, xx x’xxxxxxxxxxxxx xx xx xxxxxxx (xxxx xxx „XXXXX“) ve Xxxxxxx. |
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(2) |
Xxxxxxxxxx 2000/258/XX xxxx xxxx stanoví, xx XXXXX xxxxxxx laboratoře xx třetích zemích, xxxxx xxxxxxxxxx žádost x xxxxxxxxx xx xxxxxx provádění xxxxxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxxx očkovacích látek xxxxx xxxxxxxxx. |
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(3) |
Xxxxxxxxx xxxxx x Xxxxxxxx xxxxxxxxx xxxxxx x xxxxxxxxx xxxxxxxxxx „Xxxxxx de Xxxxxxxxx em Xxxxx xx Laboratório de Xxxxxxxxx Xxxxxxx e Xxxxxxxxx xx Instituto xx Ciências Xxxxxxxxxx xx Xxxxxxxxxxxx xx Xãx Xxxxx“. XXXXX xxx tuto xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xx xxx 24. xxxxx 2019, xxxxxx xxxxxxxxxx Komisi. |
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(4) |
Příslušný xxxxx Xxxx předložil xxxxxx o schválení xxxx xxxxxxxxxx: „Sino Xxxx World Xxxxxxxxxxx Xxxxxxxxxxxxxx Xx., Ltd (Xxxxxx)“ a „Xxxxxx Xxxxxxx Diagnostic Center xx xxx Institute xx Xxxxxx Xxxxxx xx the Xxxxxxxxx Xxxxxxx xx Xxxxxxxxxxx Xxxxxxxx“. XXXXX pro xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx hodnotící zprávu xx xxx 24. xxxxx 2019, xxxxxx xxxxxxxxxx Xxxxxx. |
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(5) |
Xxxxxxxxx orgán Xxxx xxxxxxxxx žádost x xxxxxxxx schválení xxxx laboratoří: „Xxxxxxxx Xxxxxxxxx Laboratory for Xxxxxx Rabies (Xxxxxxxxxx Xxxxxxxxxx for Xxxxxx xxx Wildlife Xxxxxxxxxx Xxxxxxxx)“ a „Centre xxx Xxxxxx Xxxxxxxx Xxxxx xx the Xxxxxxxxxx xx Xxxxxxxxxxxx xx xxx Military Xxxxxxxxxx Research Xxxxxxxxx xx the Xxxxxxx xx Xxxxxxxx Xxxxxxx Xxxxxxxx“. XXXXX pro xxxx xxxxxxxxxx xxxxxxxxxxx xxxxxxxxx hodnotící xxxxxx xx dne 24. xxxxx 2019, kterou xxxxxxxxxx Komisi. |
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(6) |
Příslušný xxxxx Xxxxx Xxxxxx xxxxxxxxx xxxxxx x xxxxxxxxx xxxxxxxxxx „Xxxxxx xxx Xxxxxxxx xxxxxxxxxxxx XXX xxxxxxxxx xxxxxxxxxx xx Xxxxxx xxx Xxxxx Xxxxxxxxxx Agency“. XXXXX xxx tuto xxxxxxxxx xxxxxxxxxxx příznivou xxxxxxxxx xxxxxx xx xxx 24. xxxxx 2019, xxxxxx xxxxxxxxxx Xxxxxx. |
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(7) |
Xxxxxxxxx xxxxx Thajska předložil xxxxxx x xxxxxxxxx xxxxxxxxxx „Xxxxxxxx Institute xx Xxxxxx Health“. XXXXX pro tuto xxxxxxxxx xxxxxxxxxxx xxxxxxxxx xxxxxxxxx xxxxxx xx xxx 24. xxxxx 2019, xxxxxx xxxxxxxxxx Xxxxxx. |
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(8) |
Xxxxxxxxx orgán Spojených xxxxx xxxxxxxxx žádost x xxxxxxxx xxxxxxxxx xxxxxxxxxx „Xxxxxxx xxx Xxxxxxx Control and Xxxxxxxxxx xx xxx Xxxxxx Xxxxxxxxxx“. ANSES xxx xxxx xxxxxxxxx xxxxxxxxxxx xxxxxxxxx hodnotící xxxxxx xx xxx 24. října 2019, xxxxxx předložila Xxxxxx. |
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(9) |
Xxxx xxxxxxxxxx xx xxxxx xxxx xxx schváleny xx xxxxxx provádění xxxxxxxxxxxxx testů pro xxxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxx proti xxxxxxxxx x xxx, koček x xxxxxx. |
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(10) |
Xxxxxxxx xxxxxxxxx xxxxx xxxxxxxxxxx xxxx x souladu se xxxxxxxxxxx Stálého xxxxxx xxx xxxxxxxx, xxxxxxx, xxxxxxxxx x xxxxxx, |
XXXXXXX XXXX XXXXXXXXXX:
Xxxxxx 1
X souladu x čl. 3 xxxx. 2 xxxxxxxxxx 2000/258/XX se pro xxxxxxxxx sérologických xxxxx xx xxxxxx xxxxxxxxx xxxxxxxxx očkovacích xxxxx xxxxx vzteklině u xxx, xxxxx x xxxxxx xxxxxxxxx tyto xxxxxxxxxx:
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x) |
Xxxxxx de Xxxxxxxxx xx Raiva Laboratório xx Xxxxxxxxx Clínica x Xxxxxxxxx xx Xxxxxxxxx xx Ciências Xxxxxxxxxx Xxxxxxxxxxxx xx Xãx Xxxxx Av. Xxxx. Lineu Xxxxxxx, 1374, xxxx 225 05508-000 Xãx Xxxxx Brazílie |
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x) |
Xxxx Tech Xxxxx Biologicals Xxxxxxxxxxxxxx Xx., Xxx (Beijing) 29 Xxxxxxxx Xxxx Xxxx. Xxxxxxxxxx Medicine Base, Xxxxxx District, Xxxxxx Xxxx |
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x) |
Xxxxxx Xxxxxxx Xxxxxxxxxx Xxxxxx Xxxxxxxxx xx Xxxxxx Xxxxxx, Xxxxxxxxx Xxxxxxx of Xxxxxxxxxxx Xxxxxxxx 21 Xxxxxxxxxx Xxxxxx, Xxxxxx District Guangzhou, Guangdong Čína |
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d) |
Xxxxxxxx Xxxxxxxxx Xxxxxxxxxx for Xxxxxx Xxxxxx (Xxxxxxxxxx Xxxxxxxxxx xxx Xxxxxx xxx Xxxxxxxx Associated Xxxxxxxx) Xxxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxxx, Xxxxxxx Xxxxxxx xx Xxxxxxxxxxxx Xxxxxxxx 666 Xxxxxxx West Xxxx, Xxxxxxx Xxxxxxx Xxxxxxxxxxx Xxxxxxxx, Xxxxxxxxx, Jilin, Xxxx |
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e) |
Centre xxx Xxxxxx Xxxxxxxx Xxxxx, Xxxxxxxxxx xx Xxxxxxxxxxxx, Xxxxxxxx Xxxxxxxxxx Xxxxxxxx Xxxxxxxxx, Xxxxxxx xx Xxxxxxxx Xxxxxxx Xxxxxxxx 666 Liuying Xxxx Xxxx, Xxxxxxx Xxxxxxx Xxxxxxxxxxx Xxxxxxxx Xxxxxxxxx, Jilin Čína |
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x) |
Xxxxxx xxx Japanese encephalitis XXX xxxxxxxxx laboratory xx xxx Animal xxx Xxxxx Xxxxxxxxxx Xxxxxx 177 Xxxxxxxx 8-ro, Xxxxxxxx-xx, Gyeongsangbuk-do, 39660, Xxxxx Xxxxx |
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x) |
Xxxxxxx xxx Xxxxxxx Xxxxxxx xxx Xxxxxxxxxx Xxxxxx Xxxxxxxxxx 1600 Xxxxxxx Xxxx, XX, Xxxxxxx, GA 30333, Xxxxxxx xxxxx xxxxxxxx |
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x) |
The Xxxxxxxx Xxxxxxxxx of Xxxxxx Xxxxxx 50/2 Xxxxxxxxxx, Xxxxxx, Xxxxxxxxx Bangkok 10900 Thajsko |
Xxxxxx 2
Xxxx xxxxxxxxxx xx určeno xxxxxxxx xxxxxx.
X Bruselu dne 14. xxxxx 2020.
Xx Xxxxxx
Xxxxxx XXXXXXXXXX
xxxxxx Xxxxxx
(1) Úř. xxxx. X 79, 30.3.2000, s. 40.